Abstract: A catheter and a method for using the catheter for site specific delivery of agents to or collecting agents from biological spaces. The catheter includes inflatable balloons which when inflated in a target segment of a biological space, create closed agent delivery pockets for the delivery or collection of agents from a defined space.

Abstract: A method of detecting vulnerable arterial plaque formed on the vessel wall in vivo is disclosed. The method comprises obtaining an image of the arterial plaque, measuring the temperature of the arterial plaque, and determining whether the plaque exhibits an elevated temperature compared to the temperature of at least one adjacent vessel wall site. The method may include determining whether the plaque exhibits an elevated temperature of between 0.4 to 4° C. above at least one adjacent vessel wall site.

Abstract: This invention provides a medical device for delivering volumetric quantities of a first and a second biochemically reactive fluid in which separate MBUs atomize the fluids. The device of the present invention includes a fluid delivery device for laparoscopically delivering fluids having two feed conduits for delivering fluid to feed ports of the mechanical breakup units, the mechanical breakup units having two feed ports for receiving fluid from the feed conduits and directing such fluid into spin chambers and funneling portions having a sloped sidewall for directing fluid from the spin chambers through an exit port. The device is suitably dimensioned for creating a spray of two fluids with different viscosities such as fibrinogen and thrombin in such a manner that the thrombin spray cone encompasses the fibrinogen spray cone at a distance of about one inch from the exit port with a 0.5 cc/second flow rate to avoid depositing unreacted fibrinogen on a surface.

Abstract: A family of extremely fine-grained alloys are used to make coatings or free-standing bodies having desirable properties for use as a heat-resistant and wear-resistant material. In an illustrative embodiment, the alloys are comprised of a multiplicity of alternate, microcrystalline or nanocrystalline films of tungsten metal and tungsten compound. The tungsten compound film may be comprised of a tungsten carbide or a tungsten boride. The tungsten films are the primary films. Their desirable characteristics, in addition to their very fine crystalline habit, per se, are the high strength, high hardness, high resilience, and high fracture energy which these fine crystallites foster. They may be manufactured by a chemical vapor deposition process in which reactive gas flows are rapidly switched to produce alternate films with abrupt hetero-junctions and thereby to produce the useful micro-crystalline habit. The unique synthesis method allows effective control of critical flaw size.

Abstract: Methods and devices are disclosed for detecting vulnerable atherosclerotic plaque, or plaque at risk of reducing blood flow in a vessel, by a identifying a region of elevated temperature along a living vessel wall. The disclosure that human atherosclerotic plaque with measurable temperature heterogeneity has the morphological characteristics of plaque that is likely to ulcerate provides a new and sensitive technique for detecting and treating these dangerous plaques before myocardial infarction and its consequences occur. The disclosed methods are advantageous over conventional plaque detection techniques because they are capable of differentiating between those plaques that are at great risk of rupture, fissure, or ulceration, and consequent thrombosis and occlusion of the artery and those that are not presently at risk. Infrared heat-sensing catheters useful for identifying potentially fatal arterial plaques in patients with disease of the coronary or other arteries are also described.

Abstract: An improved, internal combustion, reciprocating engine employs thermal regeneration to improve its efficiency and power. Regeneration is accomplished through the use of an alternating flow heat exchanger. In one embodiment the engine consists of one or more cylinders containing a pair of opposed pistons, a hot piston and a cold piston separated by a stationary regenerator. The engine is equipped with means to introduce gaseous or liquid fuel into said hot volume, means to introduce fresh working fluid and means to remove exhaust gases from the cold volume. In one embodiment one or more exhaust ports permitting the flow of exhaust fluid out of the cylinder are located between a cold piston and the thermal regenerator and one or more intake ports permitting the flow of fresh working fluid into the cylinder are located between the cold piston and the exhaust ports. The engine can provide greater expansion than compression and can provide critical and substantial improvements over previous engines.

Abstract: Surgical methods and related medical devices for treating glaucoma are disclosed. The method comprises trabecular bypass surgery, which involve bypassing diseased trabecular meshwork with the use of a seton implant. The seton implant is used to prevent a healing process known as filling in, which has a tendency to close surgically created openings in the trabecular meshwork. The surgical method and novel implant are addressed to the trabecular meshwork, which is a major site of resistance to outflow in glaucoma. In addition to bypassing the diseased trabecular meshwork at the level of the trabecular meshwork, existing outflow pathways are also used or restored. The seton implant is positioned through the trabecular meshwork so that an inlet end of the seton implant is exposed to the anterior chamber of the eye and an outlet end is positioned into fluid collection channels at about an exterior surface of the trabecular meshwork or up to the level of aqueous veins.

Abstract: This invention provides a medical device for delivering volumetric quantities of a first and a second biochemically reactive fluid comprising a first container having an opening, the first container being adapted to contain the first biochemically reactive fluid; a second container having a second fluid opening adjacent the first fluid opening, the second container being adapted to contain the second biochemically reactive fluid; a spray unit for separately atomizing the first and second biochemically reactive fluids into an aerosol with at least one energy source of a liquid energy, a mechanical energy, a vibration energy, and an electric energy; a fluid pressurizer for pressurizing the first and the second biochemically reactive fluids for delivery under pressure through the spray unit onto a surface; and wherein the first and second biochemically reactive fluids first mix on the surface.

Abstract: Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft.

Abstract: A system for delivering and implanting a radially expandable endoluminal prosthesis within a body lumen (e.g., blood vessel). The system comprises a) an introducer/dilator assembly, and b) a delivery catheter/loader assembly. The introducer/dilator assembly comprises an elongate tubular introducer sheath which may be provided with a valving assembly mounted on the proximal end thereof. Such valving assembly may incorporate i) a hemostatic valve, ii) a first sealing valve and iii) a second sealing valve, positioned in series, to prevent leakage of body fluid out of the proximal end of the introducer and to permit two or more elongate members (e.g., catheters, guidewires) having differing outer diameters to be inserted through the introducer without leakage of body fluid therefrom. A dilator, which has regionalized differences in stiffness, is initially deployable within the lumen of the introducer to facilitate advancement of the introducer to its desired location within the body.

Abstract: Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft.

Abstract: Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft.

Abstract: An apparatus and method for intraluminal delivery and deployment of an expandable prosthesis at a site within a body canal is provided. The apparatus comprises an elongated sleeve and an outer shaft disposed within the elongated sleeve and movable relative to the sleeve. A securing member is disposed on a distal area of the outer shaft. The expandable prosthesis is housed within a distal area of the elongated sleeve, and a distal area of the prosthesis is secured to the outer shaft by the securing member. The stent is deployed by displacing the sleeve in a proximal direction relative to the outer shaft to expose the stent and by releasing the stent from the securing member. If necessary, the stent can be repositioned prior to releasing the stent from the securing member.

Abstract: A controlled advancement laser ablation device is provided for precise ablation of body matter. The laser ablation device includes a laser energy transmission mechanism such as, e.g. a fiber optic fiber mounted for controlled translational longitudinal movement relative to a housing structure. A laser energy generator is optically connected to the laser energy transmission mechanism. A controlled advancement mechanism is provided in engagement with the laser energy transmission mechanism for advancing the mechanism through the housing structure at a controlled rated coordinated with the laser energy generator output to ablate body tissue. Controlled advancement mechanisms include constant and/or variable rate springs, motors, and other mechanisms which can be coordinated with the laser energy generator to advance the laser energy transmission mechanism as the targeted substance is ablated. The device is particularly suitable for use in transmyocardial revascularization (TMR) and angioplasty procedures.

Abstract: An engine structure and mechanism that operates on various combustion processes in a two-stroke-cycle without supplemental cooling or lubrication comprises an axial assembly of cylindrical modules and twin, double-harmonic cams that operate with opposed pistons in each cylinder through fully captured rolling contact bearings. The opposed pistons are double-acting, performing a two-stroke engine power cycle on facing ends and induction and scavenge air compression on their outside ends, all within the same cylinder bore. The engine includes a novel compressor arrangement having an intake valve comprising a V-shaped double reed valve with an apex pointing toward the intake port and an exhaust valve having a V-shaped double reed valve with an apex pointing away from the exhaust port. The compressor arrangement may further include rectangular intake and exhaust ports, a rectangular piston rod and rectangular crosshead bearings.

Abstract: Methods for utilizing a device for blocking (e.g., embolizing) the side branches of an anatomical passageway under endoscopic guidance. The device comprises an elongate catheter body having a side branch blocking apparatus, such as an embolization catheter, disposed therein and further incorporating an endoscope (e.g., an angioscope). The incorporated endoscope is useable to a) visually locate side branches which emanate from the anatomical passageway and b) visually observe the operation of the side branch blocking apparatus. Disclosed are methods for performing in situ embolization of the side branches of a vein, under angioscopic visualization. The endoscopic component of the device may also be utilized to visually observe the use and/or effect of one or more separate device, such as valvulotome(s) used for cutting venous valves located within the lumen of a vein.

Abstract: An engine structure and mechanism that operates on various combustion processes in a two-stroke-cycle without supplemental cooling or lubrication comprises an axial assembly of cylindrical modules and twin, double-harmonic cams that operate with opposed pistons in each cylinder through fully captured rolling contact bearings. The opposed pistons are double-acting, performing a two-stroke engine power cycle on facing ends and induction and scavenge air compression on their outside ends, all within the same cylinder bore. The engine includes a novel novel combustion chamber configuration comprising a semi-torus formed by a peripheral relief provided around the outer perimeter of each piston crown. This arrangement leaves a large central surface or squish land on each piston crown permitting a small piston clearance to be used for the purpose of generating a strong, radially-outward flow (squish) as the pistons approach each other in their cyclic motions.

Abstract: A multi-lumen catheter capable of measuring cardiac output continuously, mixed venous oxygen saturation as well as other hemodynamic parameters. The catheter is also capable of undertaking therapeutic operations such as drug infusion and cardiac pacing. The catheter includes optical fibers for coupling to an external oximeter, an injectate port and thermistor for bolus thermodilution measurements, a heating element for inputting a heat signal and for coupling to an external processor for continuously measuring cardiac output, and a distal lumen for measuring pressure, withdrawing blood, guidewire passage or drug infusion. In a preferred embodiment, the catheter includes a novel lumen configuration permitting an additional infusion lumen for either fast drug infusion or cardiac pacing.

Abstract: Methods for folding a catheter mounted balloon, and delivery catheter systems which incorporate radially expandable intraluminal devices (e.g., stents, grafts and stented grafts) which are mounted on a balloon folded in accordance with this method. The method comprises generally folding the balloon at least twice, in opposite directions, so that any rotational forces created by the unfolding of the balloon as it is inflated will counteract each other, and will thus avoid substantial rotational movement of the intraluminal device during its radial expansion.

Abstract: An externally supported, tape-reinforced tubular prosthetic graft and method of manufacturing therefore. The graft comprises a tubular base graft formed of expanded, sintered fluoropolymer material, a strip of reinforcement tape helically wrapped about the outer surface of the tubular base graft and attached thereto, and, an external support member helically wrapped around the outer surface of the reinforcement tape and attached thereto. The helical pitch of the reinforcement tape is different from the helical pitch of the external support member. Preferably, the helical pitch of the reinforcement tape is in a direction which is opposite the direction of the external support member.